phase iib clinical study of recombinant mycobacterium tuberculosis allergen esat6-cfp10

Conditions: Tuberculosis

Summary: 96 tb subjects and 96 non-tb subjects with lung disease who all meet the standard are divided into different groups through a randomized, blind methods.every subject inject intradermally esat6-cfp10 and tb-ppd in different arms of the same person.specific γ- ifn(gamma interferon) detection is needed before the injection.evaluate the sensitivity (positive coincidence rate) ,the specificity (negative coincidence rate) and the coincidence rate of esat6-cfp10 in the tuberculosis patients and non-tuberculosis patients with lung diseases, and determine the optimal dose of esat6-cfp10 for clinical auxiliary diagnosis of tuberculosis.

firstly,96 tb(tuberculosis ) subjects which meet the standard respectively are divided into different groups through a randomized, blind methods. 1. esat6-cfp10 （5μg/ml）in left arm； 2. esat6-cfp10 （5μg/ml）in right arm； 3. esat6-cfp10 （10μg/ml）in left arm； 4. esat6-cfp10 （10μg/ml）in right arm； inject intradermally esat6-cfp10 and tb-ppd(tuberculin purified protein derivative ) in different arms of the same subject.for each of the participants in this clinical research, this study uniform that left arm inject a drug(esat6-cfp10 or tb - ppd) first, observe 30 min and no no obvious adverse reaction ,then another drug(esat6-cfp10 or tb - ppd) inject in right arm. we need draw blood to detect specific γ- ifn before the injection.observe and record the vital signs (breathing, heart rate, blood pressure and temperature),the skin reaction diameter of injection site (flush and induration) , local reactions (rash, pain, itching and skin mucous membrane) and a variety of adverse events. secondly, 96 non-tb subjects with lung disease are divided into different groups and the procedure are as the same as 96 tb subjects above . finally,we evaluate the sensitivity (positive coincidence rate) ,the specificity (negative coincidence rate) and the coincidence rate of esat6-cfp10 in the tb patients and non-tuberculosis patients with lung diseases,determine the optimal dose of esat6-cfp10 for clinical auxiliary diagnosis of tuberculosis,and further evaluate the safety of esat6-cfp10 for the clinical auxiliary diagnosis of tuberculosis .

Eligibility criteria:
inclusion criteria of tb (tuberculosis ) subjects: * diagnosis tb ; * 18 to 65 years ; * consent and signed informed consent forms(icf) ; * comply with follow-up . exclusion criteria of tb (tuberculosis ) subjects: * advanced cancer, diabetes,copd in acute episodes, acute/ progressive liver disease or kidney disease, congestive heart failure, etc ; * taking part in other clinical or within 3 months involved in any other clinical; * histories of allergy ; * in pregnancy or lactation; * in a mental illness ; * any conditions affect the trial evaluation. inclusion criteria of non-tuberculosis subjects with lung disease : * diagnosis non-tuberculosis subjects with lung disease ; * 18 to 65 years ; * consent and signed signed informed consent forms(icf) ; * comply with follow-up . exclusion criteria of non-tuberculosis subjects with lung disease : * advanced cancer, diabetes,copd in acute episodes, acute/ progressive liver disease or kidney disease, congestive heart failure, etc ; * taking part in other clinical or within 3 months involved in any other clinical; * histories of allergy; * in pregnancy or lactation; * in a mental illness ; * any conditions may affect the trial evaluation.

Keywords: diagnosis of tuberculosis esat6 cfp10 skin test diagnostic test